BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    STERILE INSTRUMENT DRAPE

    K Number: K902763 · Decision Sep 20, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    26
    Registration Numbers
    26
    Same Product Code
    3
    Applicant Total
    16
    Review Days
    87

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    Basic Information

    Device Name
    STERILE INSTRUMENT DRAPE
    K Number
    K902763
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4370
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    North American Sterilization & Packaging Co.
    Date Received
    June 25, 1990
    Decision Date
    September 20, 1990
    Product Code
    HMW
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    HMW Drape, Microscope, Ophthalmic

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